Monitoring device for a therapy device and process

ABSTRACT

A monitoring device for monitoring a therapy device, for example, an anesthesia device or a respirator, is provided by which an alarm device for triggering an alarm when the value drops beyond a warning limit ( 4 ) is automatically activated when a determined therapy parameter drops beyond this warning limit ( 4 ). The warning limit ( 4 ) is set automatically in this case. In addition, a therapy device monitored by the monitoring device and especially an anesthesia device as well as a respirator are provided. A process for triggering an alarm as well as a process for treating a patient is also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 ofGerman Patent Application DE 10 2006 032 860.4 filed Jul. 14, 2006, theentire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains to a monitoring device for a therapydevice for a patient, wherein the monitoring device has a device fordetermining at least one therapy parameter; and at least one alarm thatcan be activated for triggering an alarm when the at least one therapyparameter is below a warning limit in the activated state of the alarmas well as to a therapy device. The present invention moreover relatesto a process for triggering an alarm as well as to a process fortreating a patient.

BACKGROUND OF THE INVENTION

Therapy devices, for example, anesthesia devices for anesthetizing apatient, are used in practice, as a rule, in conjunction with at leastone monitoring device for monitoring therapy parameters such asrespiration parameters, anesthesia parameters and/or vital parameters ofthe patient being anesthetized.

These monitoring devices may be directly integrated within theparticular therapy devices but also provided as independent, externalmonitoring device, and they trigger an alarm or an alarm report upon theonset of certain circumstances. The monitoring device may be designed asso-called monitors.

When such a monitoring device is used, it is common practice to presetrespective limit values for the parameters to be monitored, above orbelow which an alarm report is triggered. These limit values, which arealso called alarm limits, are usually set by the attending physician orhis team, quite generally by the operator of the therapy device.

When such a monitoring device according to the state of the art areused, errors occur in alarm triggering, which may be directly orindirectly disadvantageous for the therapy being monitored or for thehealth and/or the well-being of the patient being treated. Such an errorin alarm triggering is given, for example, when no alarm is triggered incase of an actually occurring error that should have led to an alarm(false negative alarm). This may be due to alarm limits that are set toogenerously or deactivated alarm limits. However, alarm reports are alsosent regularly in case of anesthesia or therapy taking place properlywithout the development of a situation in which an alarm should havebeen triggered (false positive alarm, also called false alarm). This maybe due to alarm limits set too strictly.

The appearance of a false negative alarm implies the great risk that thephysician, who relies upon an alarm in the case of malfunction of thetherapy device (for example, the anesthesia device) or in case ofdeviation of a parameter from its target range, detects the actuallyoccurring error only late at best due to the absence of this alarm.

False positive alarm reports or false alarms are, by contrast, notdirectly hazardous to the health of the patient, but they may beindirectly hazardous. Thus, false alarms would be suitable for divertingthe physician from his actual work or for preventing him from performinghis work. False alarms could also be hazardous because their repeatedoccurrence could give reason to the physician or his team not to paygenerally the necessary attention to future alarms, to generally ignorefuture alarms or to even deactivate the alarm means of the monitoringdevice in order to avoid future alarms altogether.

Such a deactivation by the physician, often intended as a temporarymeasure only, could regularly also occur in order to do away with alarge number of false alarms, which are due in anesthesia devices, forexample, to the curve usual for some forms of anesthesia, such as theslow build-up of a gaseous anesthetic during the induction of anesthesiaup to a target concentration. There is later a risk in this case thatone will forget to manually reactivate the alarm means. If a case oferror that does require an alarm occurs in such a case, no alarm will betriggered because of the deactivation (false negative alarm), which maybe associated with a safety risk for the patient. Lowering the alarmlimits to a generous alarm setting to avoid false alarms will in turnincrease the risk of false negative alarms, i.e., the absence ofjustified and necessary alarm reports.

SUMMARY OF THE INVENTION

The object of the present invention is therefore to create a monitoringdevice for monitoring the therapy and especially anesthesia as well as atherapy device equipped therewith and especially an anesthesia devicewith automatic activation of an alarm means to avoid or reduce at leastfalse positive alarms while ensuring at the same time the greatestpossible safety for the patient. The object of the present invention is,moreover, to provide a corresponding process for triggering an alarm aswell as a process for the treatment and especially the anesthesia of apatient.

According to the present invention, a monitoring device is provided fora therapy device of a patient, wherein the monitoring device has meansfor determining at least one therapy parameter and at least one alarmmeans that can be activated for triggering an alarm when the at leastone therapy parameter is below a warning limit in an activated state ofthe alarm means. The monitoring device has, furthermore, at least onemeans for the automatic activation of the alarm means when the at leastone therapy parameter is above a lower threshold value.

The present invention will be explained below based on the example of amonitoring device for an anesthesia device for the anesthesia of apatient by means of a gaseous anesthetic, which monitoring device islikewise covered and claimed by the present invention. The monitoringdevice for the anesthesia device represents here any kind of monitoringdevice, to which the present invention is likewise applicable. Furtherexamples according to the present invention will likewise be explainedbelow.

When the monitoring device according to the present invention is used tomonitor an anesthesia means, it has at least one means for determiningat least one minimum alveolar concentration (MAC) of this gaseousanesthetic as a therapy parameter. However, if the monitoring device isintended to monitor a therapy device other than an anesthesia device,the at least one gas may also be a gas that is not used for the purposeof anesthesia but, for example, for respiration, as this will beexplained below. Another parameter, for example, a concentration, apressure, a volume, a ratio of such parameters or changes in suchparameters may be determined instead of a minimum alveolar concentrationin such a case.

The term “minimum alveolar concentration” is used here in agreement withits use in the pertinent literature. It denotes, within the framework ofthe present invention, the value of a minimal alveolar concentration ofa gaseous anesthetic at which 50% of all patients no longer respond toan incision with a defense reaction. The underlying minimum alveolarconcentration may be a minimum alveolar concentration (MAC) notcorrected for the patient's age (called a MAC₄₀ value, for anapproximately 40-year-old patient) or even a MAC value corrected for theage of the particular patient. It is up to the person skilled in the artto take into account alternatively the age-corrected MAC value or theMAC₄₀ value when carrying out the present invention. Such adetermination of the MAC value may be carried out, for example, at shorttime intervals, e.g., every couple of milliseconds or resolved forindividual breaths (for example, once per breathing cycle). Themeasurement may be carried out as a side-stream measurement, by means ofa sample holder and using the infrared technique, or in another manner.The procedure used to determine a MAC value relative to a certainpatient and a given anesthesia situation is therefore known as such tothe person skilled in the art and is not the subject of the presentinvention.

The at least one MAC value determined by means of the monitoring deviceaccording to the present invention is a MAC value selected by the personskilled in the art. It may be an inspiratory MAC value (MAC_(insp))and/or an expiratory MAC value (MAC_(exp)) and/or a MAC value filteredas a function of the action time of the particular gaseous anestheticused (MAC_(expfilt)) of the at least one gaseous anesthetic used and/orother MAC values. If the person skilled in the art recognizes anadvantage in the determination of another MAC value not expresslymentioned here or in the use of a modified MAC value, provisions arealso made according to the present invention for determining and usingthat MAC value. It appears to the person skilled in the art from theabove that provisions are also made according to the present inventionfor determining only one MAC value.

The determination of the MAC value may be carried out now in theinspiratory breathing gas (“inspiratory MAC value”) and/or in theexpiratory breathing gas (“expiratory MAC value”) of the patient beinganesthetized, for example, in the area of the Y-piece. The term“inspiratory MAC value” therefore pertains to a MAC value at which atleast one concentration measured in the inspiration gas—especially ofthe at least one gaseous anesthetic used—is included, and the“expiratory MAC value” is at least one concentration from the expirationgas or the expired breathing gas, i.e., the concentration of at leastone determined gas in a gas mixture.

The time that elapses until the onset of the action of the gas inquestion in the body is determined by calculation at least approximatelyin the MAC value filtered as a function of the action time of the atleast one gaseous anesthetic. Various methods are known to the personskilled in the art for this filtering. The person selects the methodthat appears to that person to be best for the particular, givencircumstances. The present invention is not bound, in its most generalembodiment, to any of these filtering methods. The MAC value, whichtakes into account the action time, is filtered in one example for sucha filtering over time that elapses between the measurement of theexpiratory MAC value (MAC_(exp)) and the onset of the intended action inthe body. Thus, in case of the use of more than only one dispensedgaseous anesthetic, the resulting MAC value can be obtained from theaddition of the individual MAC values involved, which are filtered withdifferent action time constants.

The monitoring device according to the present invention has,furthermore, an alarm means that can be activated for triggering analarm when the at least one determined MAC value is below a warninglimit or drops to a value that is at or below this warning limit in anactivated state of the alarm means. This warning limit may be set as afixed limit on the anesthesia device (“on the device side”) or set bythe physician or the operator of the anesthesia device in the particularcase. An alarm is therefore triggered by the monitoring device only whenthe alarm means is activated, on the one hand, and at least one of thedetermined MAC values drops or has dropped below the warning limit, onthe other hand.

The monitoring device according to the present invention has, moreover,a means for automatically activating the alarm means. As a basicsetting, the alarm means may thus be deactivated on the device side. Theautomatic activation takes place when the at least one MAC value isabove a lower threshold value or has risen above this value. Just likethe lower warning limit, the lower threshold value may also be preset asa fixed value on the device side, but, as an alternative, it may also beset by the physician. However, it is also possible according to thepresent invention, for example, that the lower threshold value or eventhe lower warning limit is set automatically as a function of othercircumstances.

The present invention is advantageously characterized in that, on theone hand, the alarm means for triggering an alarm is automaticallyactivated only when, for example, a first phase of an anesthesia, duringwhich most of the false alarms, especially false positive alarms, aretriggered due to the slow build-up of the gaseous anesthetics or thegaseous anesthetic, has concluded and certain MAC concentrations havebeen reached in the inspiration or expiration gas. The appearance offalse alarms as well as alarms that are triggered because certain gasconcentrations could not reach or exceed a lower warning limit isadvantageously prevented hereby. Consequently, the physician is also notdiverted from work because no alarms have been triggered at all. For thesame reason, the physician has, moreover, no motivation for deactivatingthe alarm means, and consequently, the physician also cannot forget torestart the alarm function or to reactivate the alarm function, whichwould be necessary after deactivation. The safety of the patient beinganesthetized is markedly improved when the monitoring device accordingto the present invention is used.

The monitoring device according to the present invention ischaracterized, on the other hand, in that deactivation of the alarmmeans of the monitoring device, if such deactivation nevertheless didtake place, can remain without consequence. As soon as the determinedMAC value exceeds the lower threshold value, the alarm means isactivated according to the present invention by itself and above allwithout intervention on the part of the physician or his team, i.e.,automatically. The lower threshold value may be set now such that it isensured that when this threshold value is exceeded by the at least oneMAC value, for example, the above-mentioned initial phase of anesthesiais concluded with certainty. The threshold value can be set or presetgenerally such that when it is exceeded, phases of anesthesia duringwhich alarm reports regularly take place without reason will havealready been concluded.

Thus, provisions are made in a preferred embodiment of the monitoringdevice according to the present invention for the monitoring device tohave a means for automatically setting the level of the lower warninglimit. The warning limit is set by this means automatically when boththe inspiratory MAC value, the expiratory MAC value and the expiratoryMAC value of the at least one gas, which value is filtered as a functionof the action time, or at least two of the values is/are at or above alower threshold value. The value of the warning limit can be set in theparticular case as a function of parameters that the person skilled inthe art considers to be important or suitable.

It is thus advantageously ensured that the physician is relieved of thetask of setting the lower warning limit in such a way that it is adaptedto the particular case or of having to set it on the device side. Thissetting is performed automatically according to criteria set in advance,as soon as the three MAC values have risen to a level above a lowerthreshold value and it is thus ensured that a desired depth ofanesthesia or phase of anesthesia is reached. In addition, one cannotforget to set the lower warning limit if it had not been set already.This is carried out rather automatically in this embodiment, and at atime at which the setting is not a reason for false alarms. It is notedthat the action according to the present invention and the advantagesassociated herewith are also achieved if only the exceeding of the lowerthreshold value by any two MAC values is taken into account to set thelower warning limit instead of the exceeding of the lower thresholdvalue by the three MAC values mentioned as examples here.

As is provided in another preferred embodiment according to the presentinvention, the monitoring device may have for this purpose a means forautomatically setting the lower warning limit, by means of which thelower warning limit can be set at a predeterminable percentage of one ofthe MAC values determined to set the warning limit, for example, of thelowest of these MAC values. The percentage may be related here to a MACvalue of the lowest MAC value which is averaged or filtered in anothermanner. It may also be related to the MAC value at the level measuredlast. This is left up to the person skilled in the art. An essentialadvantage of this embodiment is that the warning limit is setautomatically and individually for the patient and the respirationparameters or MAC values thereof. Such a percentage may be, for example,above 50% of the lowest of the MAC values determined, preferably above60%, especially preferably between 65% and 75% and especially preferablyat 70%. Provisions may be made, especially in this embodiment of thepresent invention, for automatically adjusting the warning limit to,e.g., always 70% of the lowest MAC value in a simple manner, and aresetting of the warning limit to always higher values than before—butnot to lower values than before—is preferred. On the one hand, thispercentage guarantees the safety of the anesthesia for the patient, and,on the other hand, the distance between the warning limit and thedetermined MAC values is sufficiently great to avoid false alarms.

Yet another, likewise preferred embodiment according to the presentinvention is characterized in that it has a means for setting a maximumvalue for the lower warning limit. An advantage of this embodimentaccording to the present invention is that there is no premature alarmin case of declining MAC values because of a lower warning limit setautomatically or independently unrealistically high. The lower warninglimit could be set at such an undesirably high value, for example, dueto instantaneous freak values of the MAC value(s) being considered inthe upward direction, which are, however, not typical for this value inthe time curve of the MAC values. This also applies to an instantaneous,especially initial rise in the concentration of a gaseous anestheticintended by the physician for the purpose of more rapid build-up. Theabove-described average, which is proposed as a possibility, orfiltration according to another method, is not absolutely necessary bymeans of this embodiment according to the present invention when settingthe percentage. This advantageously leads to a simplification of thedesign of the monitoring device according to the present invention.

In another, likewise preferred embodiment according to the presentinvention, the monitoring device has a means for filtering theinspiratory MAC value over time or over a time interval. It can beadvantageously ensured hereby, in general, that individual MAC values ofa MAC value, which are excessively high or too low (so-called freakvalues), will not lead to the setting of the lower warning limit, norwill they essentially co-determine the setting of these values, becausesuch a setting based on freak values does not lead to the setting of awarning limit at the actually intended level. Therefore, this embodimentaccording to the present invention has the advantage of increasedprocess safety. Such a filtering may be based, for example, on a meanvalue method or a mean value method with sliding average (for example,over 30-sec periods). Any other method known to the person skilled inthe art, which can contribute, as was described above, to greaterprecision and/or to an increase in process safety, should likewise beconsidered to be covered by the present invention. Such a means may, ofcourse, also be provided according to the present invention forfiltering over time for the MAC value filtered as a function of theaction time regardless of any further or additional filtering of thisMAC value.

The alarm means of the monitoring device of another preferred embodimentis suitable and set up to trigger an alarm whose intensity increasesover time. The alarm therefore begins quietly and initially disturbs thepersons present in their work less than at a later point in time. Thus,the persons present do not fail to see and/or hear an alarm, on the onehand, and, on the other hand, it is not necessary to interrupt anyactivity immediately upon the onset of the alarm in order to end thealarm immediately. This is pleasant and above all advantageous above allwhen the physician or the attending therapist must walk only a few stepsto the patient or the anesthesia device and an alarm that is alreadyvery intense initially would otherwise needlessly burden the personspresent until they reach the anesthesia device. An alarm that is moreintense from the very beginning would not “alarm” the person in charge“more” but would only be more unpleasant for all persons concerned. Inaddition, in case of a gradually increasing intensity, a physician, whois still performing other tasks in the meantime, can also assess theurgency of the alarm and whether he can still conclude the work justbeing performed before he addresses those circumstances triggering thealarm. The time elapsing until the alarm is increased (i.e., until itsintensity increases) can be selected to be such that the alarm isintensified at the latest after the end of a time that corresponds to50% of the time constant of the fastest gas present in the gas mixture(i.e., the gas with the shortest time constant). This consequentlygenerates an alarm in time before the unintended waking up of thepatient.

The monitoring device may also have for this purpose a means forcalculating when a MAC value will foreseeably drop below the warninglimit, in which case the result of this calculation can be displayed ina suitable manner. This is advantageous especially when therapeuticmeasures taken by the physician and the triggering of the alarm more orless overlap. A look at the result of the calculation can alreadyrepresent the feedback to the physician to determine whether or not themeasures he was taking in the meantime (such as an increase in theconcentration of an anesthetic) will suffice, based on experience, toavoid a relevant violation of the warning limit and whether the alarm is“self-limiting” due to waiting briefly based on the measures alreadytaken and will come to an end without his intervention.

In yet another preferred embodiment according to the present invention,the monitoring device has a means for setting and/or correcting thelower warning limit in case of changes in the set values for theanesthesia on the anesthesia device. When the physician has madechanges, for example, in the respiration parameters or in the level ofthe anesthetic concentration administered, it may become necessaryhereby to change (raise or lower) the lower warning limit. The advantageof this embodiment according to the present invention is that thewarning limit is automatically adapted to the changed circumstances bymeans of the setting and/or correcting means. Avoidable alarms, which donot provide the physician with any additional information, areadvantageously avoided hereby. This resetting or correction may be takeninto account, for example, by means of a model calculation.

In yet another preferred embodiment according to the present invention,the monitoring device has a means for deactivating the alarm means.Deactivation of the alarm means can be carried out by the deactivationmeans when at least one MAC value taken into account for setting thewarning limit assumes a value lower than or equal to the lower thresholdvalue. This deactivation may take place automatically or be triggered bythe user. An advantage associated herewith is that the monitoring deviceis put into an initial state from which the lower warning limit is resetto a current value each time the MAC value rises again above the lowerthreshold value. Moreover, there are no meaningless alarms, for example,at the end of the anesthesia because of the value dropping below thewarning limit, without the physician himself having to performdeactivation of the warning limit. If the setting parameters, whichdetermine the MAC values, are known in the system, a necessarydeactivation of the alarm system or of the warning limit can be deduced,i.e., implemented, in time from the change in the setting of these MACvalues.

In yet another preferred embodiment according to the present invention,the monitoring device has means for determining at least one MAC valueas discussed above. However, unlike in the case discussed above, themeans for determining MAC values are suitable and intended fordetermining MAC values of different gases and especially differentgaseous anesthetics. By means of another means or the same means of thisembodiment, a total MAC value can be determined from the determined MACvalues of the different gases. The total MAC value is used as the basisfor monitoring the anesthesia device essentially as was described above.

For example, in the case of an anesthetic gas mixture comprising N₂O andisoflurane, the MAC_(exp) determined for N₂O is filtered with adifferent action time (action time for N₂O) than the MAC_(exp)determined for isoflurane (action time for isoflurane). The two MACvalues, thus filtered, are added to obtain MAC_(expfilt), and volumeweighting or any other suitable weighting may be performed between thesetwo gases. A relatively accurate picture of the actions of the gasmixture on the patient is thus obtained.

Another preferred embodiment is characterized in that it has a means forthe automatic activation of the alarm means when the lowest determinedMAC value or the lowest of the determined MAC values is above thethreshold value and the inspiratory MAC value, MAC_(insp), is at thesame time higher than the expiratory MAC value, MAC_(exp). Provisionsare made in yet another preferred embodiment for the alarm limit to beactivated automatically when the inspiratory MAC value, MAC_(insp), ishigher than the determined percentage (for example, 40%, 50%, 60%, 70%,80% or 90%) of the expiratory MAC value filtered as a function of theaction time of the breathing gas, MAC_(expfilt), a value higher than 80%being especially preferred.

These embodiments according to the present invention are advantageouslycharacterized in that based on the additional requirement, namely, thatthe inspiratory MAC value must be higher than the expiratory MAC valueor than a percentage of the MAC value filtered as a function of theaction time of the breathing gas before the alarm limit is set, it isensured that the anesthesia system rather than the patient is the“source” of the measured concentration of the at least one gas. In otherwords, this means that a first-time activation—or an increase—in thelower warning limit takes place only when the anesthesia is at an earlystage (i.e., at its beginning) and it is also meaningful and desired toset the warning limit. The MAC value measured in the inspiratorybreathing gas is higher than the MAC value measured in the expiratorybreathing gas at this stage. The situation is different at a later stageof anesthesia (i.e., by its intended end): The inspiratory MAC value islower here than the expiratory MAC value, because the patient breathesout more gaseous anesthetic than is supplied to him. It is no longerdesirable to raise the alarm limit at this stage. The same action isalso given when the inspiratory MAC value is measured at a percentage ofthe expiratory MAC value filtered as a function of the action time ofthe breathing gas. Thus, both cases contribute to the avoidance of thesetting of the lower warning limit, which is undesired because it isfalse, and of alarms falsely triggered hereby.

The object according to the present invention is also accomplished by atherapy device. It is accomplished, furthermore, by a process fortriggering an alarm as well as by a process for treating a patient. Theadvantages achieved hereby correspond in full measure to the advantagesdiscussed above. To avoid repetitions, reference is expressly made tothe above discussion of these advantages. It is pointed out that all thedevice features that can be found in this description of the presentinvention are also the subject of the corresponding processes accordingto the present invention. Furthermore, it is pointed out that a furtheraspect of the present invention pertains not only to therapy devicessuch as anesthesia devices, but also to other therapy devices if theperson skilled in the art recognizes that the application of the basicidea of the present invention can also be extrapolated to and/or isadvantageous for this device. This also applies to the processes. Theyare not directed solely towards the treatment, for example, anesthesia,or the respiration of a patient, but also to other applications obviousto the person skilled in the art.

The present invention was described based on the example of anesthesiaas well as a monitoring device as well as an anesthesia device used inthis connection. The essential basis was the MAC value here. However, itis obvious to the person skilled in the art that the present inventionand each of its partial aspects, variants and/or features can also bereadily extrapolated to a monitoring device (monitoring means) for othertherapy devices, in which automatic activation of an alarm means isintended.

Such therapy devices also comprise, among other things, respirators. Theexplanations given above in connection with MAC values are extrapolatedfor this to volume, pressure or concentrations as well as ratios orchanges of the gases used in the process: Such an other therapy deviceis, for example, a device for monitoring a respiratory minute volume tobe administered. If the respiration of a patient is supported by arespiration ventilator by means of this device (intensive care, homecare, anesthesia respiration), the ventilator can automatically increasethe percentage of the mandatorily administered respiratory volume, forexample, on the basis of certain values preset by the user (minimalrespiratory minute volume, CO₂ values, hemodynamic parameters or thelike) in proportion to the volume from the patient's spontaneousrespiratory activity. This increase can take place in a regulated orcontrolled manner. The risk of insufficient respiration of the patientincreases now, should this mandatory respiration be suddenly eliminated,e.g., due to a technical failure. Corresponding to the process accordingto the present invention as well as in case of the use of a meansdesigned according to the present invention, automatic activation of alower warning limit for the respiratory minute volume to be supplied bythe therapy device can take place in anticipation. The warning limit cannow be correspondingly adapted automatically to values which are to bemonitored and amount, for example, at least to about 70% of themandatory respiratory minute volume. Provisions could be made accordingto the present invention for the warning limit to be raised only but notlowered automatically. If the percentage of respiratory minute volumemandatorily supplied by the machine then drops below the automaticallyactivated warning limit (due to failure of the ventilator, leakages orthe like), a corresponding alarm is triggered. The at least one MACvalue mentioned in the description given above as well as the appendedpatent claims corresponds at least to a minimal respiratory minutevolume, a CO₂ value, a hemodynamic parameter or the like in case of thedevice being described here for monitoring a respiratory minute volumeto be administered. The above-mentioned MAC values are to becomplemented here by parameters such as minimal respiratory minutevolumes, CO₂ values, hemodynamic parameters or the like as well as anycombinations hereof.

Another example of such other therapy devices is a device for monitoringa pressure to be applied: So-called heart-lung machines, with whichoxygenation of the patient's blood is guaranteed during the surgicalprocedure, are regularly used in connection with cardiac surgery. Thelung does not contribute to the oxygenation now. It is also usually notrespirated and therefore also not monitored.

However, it is frequently necessary to prevent the lung(s) fromcollapsing by applying a constant pressure. If the patient's respirationpressure is measured during such an operation, an alarm system, whichcorrespondingly triggers an alarm when the previously prevailingrespiration pressure drops, can be automatically activated according tothe present invention. The lower warning limit may be set, for example,at 75% of the respiration pressure mean value of the last 60 sec and isautomatically increased only, but it cannot be lowered, so that an alarmwould be triggered should the value drop below the limit.

The present invention will be described in detail below on the basis ofan exemplary embodiment with reference to the drawings. The variousfeatures of novelty which characterize the invention are pointed outwith particularity in the claims annexed to and forming a part of thisdisclosure. For a better understanding of the invention, its operatingadvantages and specific objects attained by its uses, reference is madeto the accompanying drawings and descriptive matter in which a preferredembodiment of the invention is illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a graph showing the course of MAC during anesthesia over thetime t.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings in particular, the conditions corresponding toMAC values at the beginning of an anesthesia are shown at the left-handedge of the graphic view in FIG. 1. It can be recognized from FIG. 1that the inspiratory MAC value, MAC_(insp) (the corresponding curve isdesignated by 1 and is drawn as a solid line), is raised rapidly to aprominent level for the purpose of rapidly inducing anesthesia. Theexpiratory MAC value, MAC_(exp) (the corresponding curve is designatedby 2 and is drawn as a broken line), also increases with a time delay.The expiratory MAC value, MAC_(expfilt) (the corresponding curve isdesignated by reference number 3 and is drawn as a two-dot broken line),which is filtered as a function of its action beyond the blood-brainbarrier, rises with an even longer delay.

The monitoring device of the anesthesia device, by means of which theschematic curves in FIG. 1 were generated, has been set such that alower warning limit MAC_(lowtrsh) (designated by reference number 4) isactivated or set only when all three MAC values 1, 2 and 3 exceed alower threshold value 5. This happens at time 7 in FIG. 1. The lowerwarning limit 4 is seen here in the example according to FIG. 1 at about70% of the lowest of the three MAC values 1, 2 and 3, i.e., at 70% ofMAC value 3. The lower threshold value 5 may be set, for example, at 0.3MAC. Presetting a comparatively low lower threshold value 5 ismeaningful, e.g., in case of a balanced anesthesia with additionalintravenous administration of anesthetics, because this entire inventioncan, of course, be used advantageously in each embodiment for balancedanesthesia as well.

Based on the further rise of the values 1, 2 and 3 (i.e., of the valuesMAC_(insp), MAC_(exp) and MAC_(expfilt)), the lower warning limit 4(MAC_(lowtrsh)) rises between the points in time 7 and 8 to a level thatremains constant between the points in time 8 and 9. Due to the repeatedrise of the inspiratory MAC value 1 with a peak at time 10, the values 2and 3 will also rise, again with a time delay, as a result of which thelower warning limit 4 will also rise slightly between the points in time9 and 10, following the lowest of the three MAC values determined.

Line 6 (which indicates the value MAC_(lowtrsh-max)), which is alsoshown in FIG. 1, indicates a preset maximum for the automatic increaseof the lower warning limit 4. This is an upper limit set prior to theanesthesia for the lower warning limit 4, which is, however, not reachedby the lower warning limit 4 in the example shown in FIG. 1.

A drop of the inspiratory MAC value 1, which is also followed by alowering of the MAC values 2 as well as 3 with a time delay, can berecognized beginning from the time 12 in FIG. 1. Since not only the MACvalue 1 but also the MAC value 2 have dropped below the lower warninglimit 4 at time 13, the conditions for triggering an alarm are met forthe monitoring device according to this embodiment (the drop of a MACvalue below the warning limit 4 may already be sufficient for triggeringan alarm in other embodiments). The monitoring device therefore triggersan alarm between the points in time 13 and 14.

Since two MAC values (here: the MAC values 1 and 2) have already assumedvalues below the lower threshold value 5 at the time of the alarm attime 13, the physician is asked by means of a dialogue field whether thealarm device could be deactivated, for example, because the end ofanesthesia is intended. The physician answered this with a “yes” at time14, after which the lower warning limit 4 drops to its initial value andthe alarm system is thus deactivated. If MAC_(exp) is higher thanMAC_(insp), this is also an indicator for the end of anesthesia, so thatthe alarm system can be deactivated upon a “yes” answer from thetherapist or upon approval by the therapist.

It is pointed out that an upper warning limit may, of course, also beprovided besides the lower warning limit in each embodiment. All thestatements made above concerning the setting of the lower warning limitalso apply now to the upper warning limit and can be extrapolated tothis if considered by the person skilled in the art to be meaningful.

The taking into account of all three of the MAC values or of therelation thereof to activate the alarm means, as in FIG. 1,advantageously ensures that an anesthesia device monitored by means ofthe monitoring device is, indeed, also the cause of the anesthesia witha corresponding depth of anesthesia, i.e., that the patient's anesthesiacan be attributed to the gaseous anesthetics being monitored. Thisinformation is essentially attached to the inspiratory MAC value 1.

If the expiratory MAC value 2 is, moreover, also required to exceed thelower threshold value 5, as in this preferred embodiment according toFIG. 1, this increases the safety of the process further due to the factthat a time shift between the reaching of an inspiratory concentrationand the same concentration in the expiratory breathing gas due todiffusion processes and shifts between compartments of the body is takeninto account, which contributes to a more precise information on theanesthesia.

If, moreover, the means for automatically setting the lower warninglimit 4 of the monitoring device also takes into account the value ofthe MAC value 3 of the at least one gaseous anesthetic, which isfiltered as a function of the action time, or the exceeding of the lowerthreshold value 5 by this MAC value 3 in case of activation of the alarmmeans, the action of the gaseous anesthetic being used on cerebralprocesses is additionally taken into account. The expiratory MAC value 3filtered as a function of the action time is to be defined as anindicator of the depth of anesthesia, and it takes into account thepassage of the gaseous anesthetic being used through the blood-brainbarrier, as was already explained above. Thus, it is a more preciseparameter of anesthesia than MAC_(exp) alone. It is expressly pointedout that FIG. 1 shows the case in which only one gaseous anesthetic isused. In the case discussed in detail above, in which not only one gasbut a gas mixture is used, the total MAC_(expfilt), filtered as afunction of the individual action times of the particular individualgases involved, replaces the MAC value 3 according to FIG. 1.Furthermore, a total MAC_(insp) and a total MAC_(exp) can replace theMAC values 1 and 2.

It applies to the means used to carry out the present invention that ameans can definitely also perform different tasks. Thus, a means for,e.g., determining MAC values and at the time for setting the lowerwarning limit and/or additional functions may be able to be used.

Provisions are also made according to the present invention for workingwith more than only one lower warning limit. Thus, the person skilled inthe art may provide different warning limits for different MAC values,and a plurality of means are used to determine them, set them, etc. Eachof these warning limits may be designed as explained above.

Moreover, it is obvious to the person skilled in the art that acombination of the determination of at least one MAC value and thedetermination of at least one additional variable, which is not a MACvalue, is possible in each embodiment of the present invention. Such anadditional variable may be, for example, a volume, a volume flow, apressure or the like. It is thus possible according to the presentinvention especially to set the lower warning limit, taking into accountat least one MAC value and at least one other variable. It is obvious inthis connection that when different variables (for example, a MAC valueand a volume value) are determined and used, it is also possible to takeinto account different lower threshold values (a threshold value for theMAC value and another for the volume value), which must each be exceededin order to set the lower warning limit.

The present invention proposes a monitoring device for monitoring atherapy device, for example, an anesthesia device or respirator, bymeans of which an alarm means for triggering an alarm when the valuedrops below a lower warning limit is automatically activated when atleast one determined therapy parameter drops below this lower warninglimit 4. The lower warning limit (warning limit) is first setautomatically in this case. In addition, a therapy device monitored bymeans of the monitoring device according to the present invention andespecially an anesthesia device as well as a respirator are proposed.The present invention proposes, furthermore, a process for triggering analarm as well as a process for treating a patient.

While specific embodiments of the invention have been shown anddescribed in detail to illustrate the application of the principles ofthe invention, it will be understood that the invention may be embodiedotherwise without departing from such principles.

1. A monitoring device for a therapy device for a patient, themonitoring device comprising: determination means for determining atherapy parameter; alarm means that can be activated to an activatedstate for triggering an alarm when said therapy parameter is beyond awarning limit in the activated state of said alarm means; automaticalarm means for automatically activating the alarm means when thetherapy parameter is beyond a threshold value.
 2. A monitoring device inaccordance with claim 1, further comprising a means for setting amaximum value for said warning limit.
 3. A monitoring device inaccordance with claim 1, further comprising a means for filtering thetherapy parameter over a time period.
 4. A monitoring device inaccordance with claim 1, further comprising a means for filtering bymeans of a sliding mean value.
 5. A monitoring device in accordance withclaim 1, further comprising a means for setting and/or correcting saidwarning limit in case of changes in set values by means of a modelcalculation.
 6. A monitoring device in accordance with claim 1, furthercomprising a means for deactivating the alarm means when a therapyparameter taken into account for setting said warning limit assumes avalue equal to or lower than said threshold value.
 7. A monitoringdevice in accordance with claim 1, further comprising a means forautomatically setting said warning limit during anesthesia by means of agas when a minimum alveolar concentration (MAC) value of the gas isabove a lower threshold value.
 8. A monitoring device in accordance withclaim 7, further comprising a means for automatically setting saidwarning limit at a value that equals a predeterminable percentage of thelowest of the MAC values taken into account for setting said warninglimit, an inspiratory MAC value and/or expiratory MAC value and/or a MACvalue filtered as a function of the action time and/or another MACvalue, of the gas.
 9. A monitoring device in accordance with claim 7,wherein said alarm means is activated for triggering an alarm when saidinspiratory MAC value and said expiratory MAC value drop beyond saidthreshold value.
 10. A monitoring device in accordance with claim 7,wherein said alarm means has an alarm intensity increasing over thecourse of time and/or for calculating a point in time at which said MACvalue filtered as a function of the action time of the gas will dropbeyond said lower threshold value.
 11. A monitoring device in accordancewith claim 10, further comprising a means for calculating the point intime of the alarm as a function of an action time constant of theparticular, fastest acting gas in case of the use of two or more gases.12. A monitoring device in accordance with claim 7, further comprising ameans for determining a MAC value of each gas in case of the use of twoor more gases and a means for determining a respective correspondingtotal MAC value.
 13. A monitoring device in accordance with claim 1,wherein the monitoring device is in combination with therapy devicecomponents to form a therapy device.
 14. A process for triggering analarm during the treatment of a patient via a monitoring device, theprocess comprising the steps of: determining a therapy parameter;triggering an alarm by an alarm device that can be activated in anactivated state of the alarm means when the therapy parameter passesbeyond a warning limit; automatically activating the alarm means whenthe therapy parameter exceeds a threshold value.
 15. A process inaccordance with claim 14, wherein a maximum value is determined for saidwarning limit.
 16. A process in accordance with claim 14, wherein atherapy parameter is filtered over a time period.
 17. A process inaccordance with claim 14, wherein a filtering of the therapy parameteris performed by means of a sliding mean value.
 18. A process inaccordance with claim 14, wherein changes in set values are taken intoaccount by means of a model calculation for setting and/or correctingsaid warning limit.
 19. A process in accordance with claim 14, whereinsaid warning limit is set during anesthesia by a gas when a MAC value ofthe gas exceeds a lower threshold value.
 20. A process in accordancewith claim 19, wherein said warning limit is set at a value that equalsa predetermined percentage of the lowest of the values taken intoaccount for setting said warning limit from a group of MAC values, whichcomprises an inspiratory MAC value and/or an expiratory MAC value and/ora MAC value filtered as a function of the action time of the gas and/oranother MAC value.
 21. A process in accordance with claim 19, wherein analarm is triggered when said inspiratory MAC value and said expiratoryMAC value drop beyond said threshold value.
 22. A process in accordancewith claim 19, wherein the alarm takes place with an intensityincreasing over the course of time and/or a point in time at which saidMAC value, filtered as a function of the action time, will drop beyondsaid lower threshold value is calculated.
 23. A process in accordancewith claim 19, wherein a calculation of the point in time of the alarmis performed as a function of an action time constant of the particular,fastest acting gas if two or more than two gases are used.
 24. A processin accordance with claim 19, wherein the alarm device is deactivatedwhen a value taken into account for setting said warning limit assumes avalue equal to or lower than said lower threshold value.
 25. A processin accordance with claim 19, further comprising the steps of:determining a MAC value of each gas in case of the use of two or moregases; and determining a respective corresponding total MAC value.
 26. Aprocess in accordance with claim 14, further comprising using themonitoring device as part of a therapy device.
 27. A process inaccordance with claim 26, further comprising using the therapy devicefor treating a patient based on at least one therapy parameter.
 28. Atherapy device for a patient, the therapy device comprising: therapymeans for treating a patient based on at least one therapy parameter; amonitoring device including determination means for determining thevalue of one of the therapy parameters, an alarm device in one of anactivated state and a none activated state, said alarm triggering analarm when the one of the therapy parameters has a value beyond awarning limit in the activated state of said alarm device; automaticalarm means for automatically activating the alarm means when thetherapy parameter is beyond a threshold value.